510(k) Premarket Notification

• Device Classification Name: instrumentation for clinical multiplex test systems
• 510(K) Number: K121399
• Model: F3DIVD-CAL-K25, F3DIVD-PVER-K25, 40-5000
• Device Name: LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
• Applicant: LUMINEX CORP.; 12212 technology blvd; austin, TX 78727
• Contact: oliver meek
• Regulation Number: 862.2570
• Classification Product Code: NSU
• Date Received: 05/09/2012
• Decision Date: 01/09/2013
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Clinical Chemistry
• Review Advisory Committee: Immunology
• statement: statement
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No